Investigating the Genetic Basis of Typical Hypoadrenocorticism (Addison’s Disease) in Standard
Poodles
Owner Consent Form for Dogs Not Previously Diagnosed with Addison’s Disease
Purpose of Study
Primary hypoadrenocorticism (Addison’s disease) is a common endocrine disorder affecting Standard
Poodles. Affected dogs often have vague signs including decreased appetite, lethargy, nausea,
vomiting, diarrhea, and gastrointestinal pain. In times of acute crisis or stress, dogs with Addison’s
disease can develop severe dehydration that progresses to the point of collapse, low blood pressure, and
life-threatening electrolyte abnormalities. The purpose of this study is to determine the genetic cause(s)
of this disease in Standard Poodles. Our hope is that by better understanding the reasons why this
disease develops, we can screen dogs before they start to show signs of the disease, and also help
breeders tailor their breeding programs. This work may also indirectly help with our understanding of
Addison’s disease in humans.
Who is Performing this Study?
This study is being performed at North Carolina State University College of Veterinary Medicine
Center for Comparative Medicine and Translational Research. The principal investigator is Dr.
Katharine Lunn, a board-certified internal medicine specialist who has a special interest in endocrine
diseases. The DNA analysis is performed in the Veterinary Genetics Laboratory at NCSU under the
supervision of Dr. Kathryn Meurs and Dr. Steven Friedenberg, both of whom are board-certified
specialist veterinarians with a special interest in genetics.
Summary of Procedures to be Performed on Your Dog
If you consent to participation in this study, we will take a 10ml blood sample (2 teaspoonsful) from
your dog to evaluate his/her genetic makeup, and measure cortisol levels. If the cortisol is normal, that
will allow us to say that your dog is free of Addison’s disease; however we cannot prove the presence
of Addison’s disease with this test.
There is no cost for participation in this study. The study investigators will pay for sending the blood
samples to NCSU, and for the cortisol measurement. The cortisol results will be provided to you and
your veterinarian, along with an interpretation of the results.
I understand that the information obtained in this study may not directly benefit my pet, but will
provide veterinarians with valuable information and knowledge about Addison’s disease in dogs. The
results of this study may be published in a scientific journal or be presented at a conference, but neither
my pet nor my family will be identified in any publications or presentations. My participation in this
study is entirely voluntary and my refusal to participate will not affect my pet’s care in any way.
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Owner Consent
I have been given the opportunity to ask questions and to have them answered to my satisfaction. I am
welcome to contact the principal investigator by telephone or e-mail if I have additional questions
regarding this study. Dr. Lunn may be reached at kflunn@ncsu.edu or at 919-513-6701.
By signing below, I acknowledge that I am at least 18 years of age, and I consent to having the
described procedure(s) performed on my dog for the purposes of this study.
Medical Record/Case #
Pet’s Name
__________________
Date
_____________________________
_______________________________________________________________________
Patient Medical Record Label (if applicable)
Client/Owner/Agent’s Printed Name
_______________________________________________
Client/Owner/Agent’s Signature
_______________________________________________
Clinician/Attending Staff Signature
_______________________________________________
Summary of the Study Investigating the Genetic Basis of Typical Hypoadrenocorticism
(Addison’s Disease) in Standard Poodles
1. First we will make sure your dog’s health will not be negatively affected by a blood draw.
2. If your dog is healthy enough for a blood draw, and you agree to participate in the study, we will
take 10 ml of blood (2 teaspoonsful).
Answers to Your Questions about the Clinical Study
1. What is Addison’s disease?
Addison’s disease is an endocrine (hormonal) disease in which there is loss of function of the
adrenal cortex. This results in loss of hormones that are essential for life. Fortunately, if it is diagnosed
promptly, Addison’s disease is very treatable, and affected dogs can have a normal lifespan.
2. Why are veterinarians at North Carolina State University studying Addison’s disease?
Addison’s disease is believed to be an immune-mediated disease. This means that the dog’s own
immune system attacks the adrenal glands, causing damage that eventually leads to loss of hormone
production. Addison’s disease in humans is likely immune-mediated too. Veterinarians at NCSU are
interested in studying a variety of immune-mediated diseases. Addison’s disease in Standard Poodles is
particularly important to study because it is most likely inherited in this breed. We are studying the
disease by analyzing the DNA of Standard Poodles with and without Addison’s disease.
3. What will you do with the blood from my dog?
The blood will be forwarded to the Veterinary Genetics Laboratory at NCSU where the DNA
(genes) will be extracted and stored. Once we have enough samples from Standard Poodles we will
begin to analyze and compare the DNA to see if we can find a mutation (change in the genes that
causes the disease). We will also measure cortisol levels in the blood. If the cortisol is normal we can
confirm that your dog does not have Addison’s disease. However we cannot use this test to diagnose
Addison’s disease. That would require an ACTH stimulation test – please discuss this with your
veterinarian if you have questions about that test.
4. What are the risks to my dog if he or she is in this study?
We do not expect any additional risks from the study. We will be drawing a small amount of
blood that is typically used for standard blood tests.
5. Will the results of the DNA analysis affect the treatment of my dog?
No – the results will have no effect on your pet or the treatment (s)he receives.
6. What is the benefit to my pet or me if I allow my pet to be in the study?
The main benefit is that it may help us to better understand and diagnose Addison’s disease in
dogs, with the potential to help breeders screen for the disease in the future.
7. Is there a disadvantage or penalty to me if I decide not to include my pet in this study?
No. Your dog will receive the same medical care, regardless of your participation.
Thank you very much – your participation is greatly appreciated.